⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SunMed Holdings, LLC: Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicabl

Medical DevicesSource: FDA (device) · Date: 2026-02-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
SunMed Holdings, LLC
Product
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Reason / hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Classification
Class I
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Recall initiated
2025-12-15
Code info
Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967
Product quantity
20583
Voluntary mandated
Voluntary: Firm initiated
City
Grand Rapids
State
MI
Country
United States
Event id
98208
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